Z-0202-2009

Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10...

Name: Z-0202-2009 Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10...
Creator: Draeger Medical, Inc.
Published: 2008-10-03
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2008-10-03 / Terminated / root cause: software

FDA source

Draeger Medical, Inc. began a recall of Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300 on 2008-10-03. The reason FDA records is "May experience an interruption of ventilation for approximately 5 seconds". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0202-2009
Status: Terminated
Initiated: 2008-10-03
Posted: 2008-10-27
Terminated: 2009-10-16
Recalling firm: Draeger, Inc.
Product: Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: May experience an interruption of ventilation for approximately 5 seconds
Root cause tag: software
FDA root cause: Software design
Action: The firm issued an Urgent - Medical Device Recall letter dated September 2008. Software version 1.10 may under specific conditions experience an interruption of ventilation for approximately 5 seconds. During that time period, the patient airway pressure may drop to zero. This phenomenon was identified by Draeger engineers and to date has not been reported by any user. The firm's investigations revealed that when ventilating in BIPAP mode with the pressure rise time (Ramp) set to the highest setting and the expiration time set to exactly 0.5 seconds, the inspiration phase can coincide with the internal auto zero function of the device. Under these circumstances a pressure spike will occur upon reaching Pmax +5mbar (cmH2O) which with software version 1.10 will lead to the inspiratory phase stopping. Ventilation will resume after approximately 5 seconds. The device will generate a Paw Measurement INOP alarm. Until the new software is available, customers are being instructed to avoid the use of the following combination of settings: 1) BIPAP mode; 2) Ramp = highest, and 3) Texp = 0.5 seconds.
Quantity in commerce: 50 units
Distribution: Nationwide Distribution --- including states of AZ, CA, FL, IL, IN, KY, LA, ME, MI, MO, NC, NE, NJ, NY, OH, PA, TX, UT, VT, WA, WV, and WY.
Product codes and lots: Serial numbers SRZA-0182 and higher tahn 0182, SRZB-xxxx, SRZC-xxxx, SRZD-xxxx, SRZE-xxxx, SRZF-xxxx, SRZH-xxxx, and SRZJ-xxxx. Note that xxxx stands for numbers 0001 through 9999.

Product code CBK

K062267Class IIOxylog 3000Drager Medical B.V. / cleared 2006-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)